The 17th Edition of the Japanese Pharmacopoeia (JP) was promulgated by Ministerial Notification No.64 of the Ministry of Health, Labour and Welfare (MHLW) on March 7, 2016.
In July 2016, the Committee on JP established the basic principles for the preparation of the JP 18th Edition, setting out the roles and characteristics of the JP, the definite measures for the revision, and the date of the revision.
It was agreed that the JP should provide an official standard, being required to assure the quality of medicines in Japan in response to the progress of science and technology and medical demands at the time. It should define the standards for specifications, as well as the methods of testing to assure overall quality of all drugs in principle, and it should have a role in clarifying the criteria for quality assurance of drugs that are recognized to be essential for public health and medical treatment.
The JP has been prepared with the aid of the knowledge and experience of many professionals in the pharmaceutical field. Therefore, the JP should have the characteristics of an official standard, which might be widely used by all parties concerned, and it should play an appropriate role of providing information and understanding about the quality of drugs to the public. Moreover, as a pharmaceutical quality standard, it should contribute promoting and maintaining of advancedness as well as international consistency and harmonization of technical requirements in the international community.
At the Committee, the five basic principles of JP, which we refer to as the "five pillars", were established as follows: 1) Including all drugs which are important from the viewpoint of health care and medical treatment; 2) Making qualitative improvement by introducing the latest science and technology; 3) Further promoting internationalization in response to globalization of drug market; 4) Making prompt partial revision as necessary and facilitating smooth administrative operation; and 5) Ensuring transparency regarding the revision, and disseminating the JP to the public. It was agreed that the Committee on JP should make efforts, on the basis of these principles, to ensure that the JP is used more effectively in the fields of health care and medical treatment by taking appropriate measurements, including getting the understanding and cooperation of other parties concerned.
It was also agreed that JP articles should cover drugs, which are important from the viewpoint of health care and medical treatment, clinical performance or merits and frequency of use, as soon as possible after they reach the market.
The target date for the publication of JP 18th Edition (the Japanese edition) was set as April 2021.
JP drafts are discussed in the following committees that were established in the Pharmaceuticals and Medical Devices Agency: Expert Committee; Sub-expert Committee; Sub-committee on Manufacturing Process-related Matters; Committee on Chemicals; Committee on Antibiotics; Committee on Biologicals; Committee on Crude Drugs; Committee on Pharmaceutical Excipients; Committee on Physico-Chemi-cal Methods; Committee on Drug Formulation; Committee on Physical Methods; Committee on Biological Methods; Committee on Nomenclature for Pharmaceuticals; Committee on International Harmonization; and Committee on Reference Standards. Furthermore, working groups are established under the Expert Committee, Committee on Pharmaceutical Excipients, Committee on Physico-Chemical Methods and Committee on Drug Formulation.
The committees initiated deliberations on several revisions.
Draft revisions covering subjects in General Notices, General Rules for Preparations, General Tests, Monographs, Ultraviolet-visible Reference Spectra and Infrared Reference Spectra for which discussions were finished between April 2017 and November 2018, were prepared for a supplement to the JP 17.
Numbers of discussions in the committees to prepare the supplement drafts were as follows: Expert Committee (11, including a working group); Sub-committee on Manufacturing Process-related Matters (6), Committee on Chemicals (18), Committee on Antibiotics (3); Committee on Biologicals (7); Committee on Crude Drugs (15); Committee on Pharmaceutical Excipients (10); Committee on Physico-Chemical Methods (11, including a working group); Committee on Drug Formulation (19, including working groups); Committee on Physical Methods (7); Committee on Biological Methods (6); Committee on Nomenclature for Pharmaceuticals (5); Committee on International Harmonization (4).
It should be noted that in the preparation of the drafts for the supplement, generous cooperation was given by the Pharmaceutical Technology Committee of the Kansai Pharmaceutical Industries Association, the Pharmacopeia and CMC Committee of the Pharmaceutical Manufacturers' Association of Tokyo, the Tokyo Crude Drugs Association, the International Pharmaceutical Excipients Council Japan, the Home Medicine Association of Japan, the Japan Kampo Medicines Manufacturers Association, the Japan Flavor and Fragrance Materials Association, the Japan Medical Plants Federation, the Japan Pharmaceutical Manufacturers Association, the Federation of Pharmaceutical Manufacturers' Association of Japan, the Parenteral Drug Association Japan Chapter, the Japan Reagent Association, the Japan Oil-seeds Processors Association, the Japan Analytical Instruments Manufacturers' Association, and the Asian Society of Innovative Packaging Technology.
The draft revisions were examined by the Committee on JP in January 2019, followed by the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) in March 2019, and then submitted to the Minister of Health, Labour and Welfare. In the Committee on JP, Mitsuru Hashida took the role of chairman from January 2011 to June 2019.
In consequence of this revision, the JP 17th Edition carries 2008 articles, owing to the addition of 34 articles and the deletion of 3 articles.

Preface i

Supplement II to The Japanese Pharmacopoeia, Seventeenth Edition 2877-2991

      General Notices 2877

      General Rules for Preparations 2879

      General Tests, Processes and Apparatus 2881

      2.01 Liquid Chromatography 2881

      2.26 Raman Spectroscopy 2882

      2.46 Residual Solvents 2884

      2.51 Conductivity Measurement 2891

      2.66 Elemental Impurities—Procedures 2893

      6.16 Rheological Measurements for Semi-solid Preparations 2896

      6.17 Insoluble Particulate Matter Test for Therapeutic Protein Injections 2900

      9.01 Reference Standards 2901

      9.21 Standard Solutions for Volumetric Analysis 2901

      9.22 Standard Solutions 2901

      9.41 Reagents, Test Solutions 2901

      9.42 Solid Supports/Column Packings for Chromatography 2908

Official Monographs 2909

Crude Drugs and Related Drugs 2973

Infrared Reference Spectra 2985-2987

Ultraviolet-visible Reference Spectra 2989-2991

General Information

G1 Physics and Chemistry

      Control of Elemental Impurities in Drug Products 2993

G3 Biotechnological/Biological Products

      Host Cell Protein Assay 2997

      Total Protein Assay 3000

G4 Microorganisms

      Media Fill Test (Process Simulation) 3000

      Microbiological Environmental Moni-toring Methods of Processing Areas for Sterile Pharmaceutical Products 3000

      Parametric Release of Terminally Steri-lized Pharmaceutical Products 3000

G5 Crude Drugs

      Purity Tests on Crude Drugs using Genetic Information 3000

      On the Scientific Names of Crude Drugs listed in the JP 3005

G8 Water

      Quality Control of Water for Pharma-ceutical Use 3006

G10 Others

      Basic Concepts for Quality Assurance of Drug Substances and Drug Products 3006

      Concept on Impurities in Chemically synthesized Drug Substances and Drug Products 3008

      Glossary for Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS) 3010

      International Harmonization Implemented in the Japanese Pharmaco-poeia Seventeenth Edition 3014

Index 3019

Index in Latin Name 3039

Index in Japanese 3041

中国医科院医学信息研究所